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Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial. A multicentre, randomised controlled trial: design and methodology
  1. Gus Gazzard1,2,
  2. Evgenia Konstantakopoulou1,2,3,
  3. David Garway-Heath1,2,
  4. Keith Barton1,
  5. Richard Wormald1,2,
  6. Stephen Morris4,
  7. Rachael Hunter5,
  8. Gary Rubin2,
  9. Marta Buszewicz6,
  10. Gareth Ambler7,
  11. Catey Bunce1,8,9
  12. on behalf of the LiGHT Trial Study Group
    1. 1 NIHR Biomedical Research Centre at Moorfields , Eye Hospital NHS Foundation Trust, London, UK
    2. 2 Institute of Ophthalmology, University College, London, UK
    3. 3 Centre for Public Health Research, School of Health Sciences, City University, London, UK
    4. 4 Department of Applied Health Research, Institute of Epidemiology and Health Care, University College London, London, UK
    5. 5 Priment Clinical Trials Unit, University College London, Royal Free Medical School, London, UK
    6. 6 Research Department of Primary Care and Population Health, University College Medical School, London, UK
    7. 7 Department of Statistical Science, Faculty of Mathematics and Physical Sciences, University College London, London, UK
    8. 8 International Centre for Eye Health (ICEH), Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK
    9. 9 Department of Primary Care and Public Health, King's College London, London, UK
    1. Correspondence to Gus Gazzard, NIHR Biomedical Research Centreat Moorfields, Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, 162 City Road, EC1V 2PD, London, UK; gusgazzard{at}gmail.com

    Abstract

    Purpose The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

    Design The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis.

    Conclusions The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication.

    Trial registration number ISRCTN32038223, Pre-results.

    • glaucoma
    • treatment lasers
    • intraocular pressure

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    Footnotes

    • Contributors GG led the initial conception and design of the trial and writing the protocol, acquired funding and ethics approval, is the chief investigator of the trial, and was a major contributor in writing the manuscript. DG-H was a major contributor to the design of the trial and the trial protocol, and was involved in the drafting of the manuscript and critical revision of the study design. EK wrote the manuscript together with GG and is involved in the acquisition of the data. KB was involved in the drafting of the protocol and critical revision of the study design. RW was involved in the drafting of the manuscript and critical revision of the study design and protocol. SM and RH contributed to the design of the outcome measures and the data to be collected, and was involved in the drafting of the manuscript. GR was involved in the drafting of the manuscript and critical revision of the study design. MB contributed in overlooking the conduct of the trial and was involved in the drafting of the manuscript. GA contributed in the design of the outcome measures and the data to be collected, and was involved in the drafting of the manuscript. CB contributed in the design of the outcome measures and the data to be collected, and was involved in the drafting of the manuscript. All authors read and approved the final manuscript.

    • Funding The trial was funded by the National Institute of Health Research Health Technology Assessment Panel (Project reference number 09/104/40) and was sponsored by Moorfields Eye Hospital NHS Foundation Trust. The sponsor or funding organisation had no role in the design or conduct of this research. This report presents independent research commissioned by the NIHR; the views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the HTA programme or the Department of Health.

    • Competing interests GG, DG-H, KB, RW, SM, RH, GR, MB, GA and CB have received a grant from the National Institute for Health Research for the submitted work. DG-H and RW have received financial support through the Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology. GG received a research grant from Lumenis prior to the submitted work. GG, DG-H and KB have conflicts of interest outside the submitted work.

    • Ethics approval The City Road and Hampstead Research and Ethics Committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement There are no additional data at the moment.

    • Collaborators The LiGHT Trial Study Group: Rupert Bourne, David Broadway, Amanda Davis, Anurag Garg, Yuzhen Jiang, Sheng Lim, Joanna Liput, Timothy Manners, Neil Nathwani, Nicholas Strouthidis, Victoria Vickerstaff, Sarah Wilson, Haogang Zhu.

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